November 10, 2004|By Julie Bell | Julie Bell,SUN STAFF
Rep. Elijah E. Cummings urged Maryland lawmakers yesterday to enact legislation to strengthen medical laboratory oversight and protect whistle-blowers - steps designed to ensure that testing problems discovered at Maryland General Hospital this year don't happen elsewhere.
Cummings, a Baltimore Democrat, has introduced similar federal legislation. But he told the state Senate's Education, Health and Environmental Affairs Committee that the General Assembly has the ability to move more quickly than a sometimes lumbering Congress.
"I want the state of Maryland to be an example for the entire country of what other states can do," Cummings said in an impromptu news conference after his testimony in Annapolis.
Sen. Paula C. Hollinger, a Baltimore County Democrat and the committee's chairwoman, said legislation would be drafted and considered at the panel's meeting next month.
She said it would include whistle-blower protection and require the regulatory bodies that oversee medical labs to share their reports - something that didn't happen immediately in the Maryland General case.
The legislation would reinforce steps authorities have taken to improve laboratory regulations after the discovery that Maryland General had sent out more than 400 potentially faulty hepatitis and HIV test results in 2002 and last year.
The lab's problems have since been corrected, officials say.
The problems at Maryland General have now prompted four state and federal legislative hearings, a state Medicaid fraud investigation and a probe by the U.S. Health and Human Services inspector general's office.
They have also brought to light serious deficiencies, including:
Whistle-blowers who alerted their bosses and state regulators to the problems said they subsequently were intimidated by laboratory supervisors, who have now been replaced.
State, federal and private inspection agencies charged with ensuring that laboratories provide accurate test results were not sharing information about the allegations at Maryland General or their findings.
Cummings and others say the lack of communication caused delays in correcting problems.
The state effectively ceded much of its authority over certain laboratories to private agencies - such as the College of American Pathologists (CAP), which accredited Maryland General - without a thorough review of whether the agency standards meet state licensing requirements.
Historically, if a private agency accredited a laboratory, the state automatically considered the lab compliant with state requirements.
Yesterday, S. Anthony McCann, Maryland's new secretary of health, said the state is reviewing the standards of each private inspection agency and expects to continue using their services.
However, this state is now reviewing private-agency inspection reports following up on problems.
Currently, about 600 large medical laboratories handle tests complex enough to require a state inspection every two years.
The state has five laboratory inspectors who handle the bulk of those inspections but relies on private inspection agencies to handle the 171 labs they accredit.
Cummings' federal legislation would protect whistle-blowers in laboratories from retaliation.
It would require state, federal and private inspection agencies to share reports about lab problems and require that lab inspections be conducted without warning, preventing workers from cleaning up problems in advance.
Cummings and Indiana Rep. Mark E. Souder, the Republican chairman of a House subcommittee investigating laboratory oversight, also have requested that the Government Accountability Office investigate the relative effectiveness of state, federal and private inspection agencies.
